This invention is concerned with improvements in and relating to laxative compositions and the manufacture thereof.
Orally administrable compositions containing a stool softener in combination with a stimulant laxative are known and such compositions may, for example, take the form of suspensions containing the active ingredients in appropriate liquid carriers for oral administration.
It has now been found, in accordance with the present invention, that a surprisingly high dose of a laxative composition can be incorporated in a small size of hard gelatin capsule by dispersing and dissolving the stimulant laxative in molten stool softener and filling the resultant molten dispersion into capsules. The resultant composition thus provides an unexpectedly high unit dose of the laxative composition in a pharmaceutical form which and shape for elegant, convenient and reliable administration to patients.
Conventionally a unit dosage form is prepared by compressing powders into tablets or encapsulating powders into hard gelatin capsules. To achieve satisfactory powder flow and either compression or encapsulation properties, it is conventionally necessary to formulate a product with excipients such as diluents, compression aids, binders, flow aids and lubricants. This is especially true when one or more of the active ingredients has undesirable physicochemical properties, for example is waxy and/or sticky, which make incorporating the ingredient in a conventional dosage form particularly difficult. Furthermore to ensure that the resulting dosage unit will break up and dissolve after administration it is usually necessary to add a disintegrant. These excipient materials add considerably to the volume of the dosage form, and may limit the amount of active ingredient(g) which may be incorporated in a unit dosage form of acceptable size and volume to ensure acceptance by a patient.